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Phase I/II study of tandem cycles of high-dose chemotherapy followed by autologous hematopoietic stem cell support in women with advanced ovarian cancer
  1. A. Tiersten*,
  2. M. Selleck,
  3. D. H. Smith,
  4. I. Wertheim§,
  5. E. Kaufman,
  6. D. Hershman,
  7. L. T. Vahdat,
  8. D. G. Savage,
  9. R. B. Macarthur and
  10. C. Hesdorffer
  1. *Division of Oncology, New York University, New York, New York
  2. Department of Medicine, Herbert Irving Comprehensive Cancer Center, New York, New York
  3. Hackensack University Medical Center, Hackensack, New Jersey
  4. §Stamford Health System, Stamford, Connecticut
  5. Weill Medical College of Cornell University, New York, New York
  6. Columbia Presbyterian Medical Center, New York, New York
  1. Address correspondence and reprint requests to: Amy Tiersten, MD, Division of Oncology, New York University, 160 East 32nd Street, 2nd Floor, New York, NY 10016, USA. Email: Amy.Tiersten{at}


The objectives of this study were to investigate the tolerability of a novel high-dose chemotherapy (HDC) regimen with peripheral blood progenitor cell (PBPC) support in patients with pretreated advanced ovarian cancer and to determine the maximum-tolerated dose (MTD) of topotecan in this setting. Advanced ovarian cancer patients previously treated with platinum-based first-line therapy were enrolled. After PBPC mobilization and harvesting, patients received three consecutive cycles of HDC with PBPC support. Cycle 1 was carboplatin area under the concentration curve 20 and paclitaxel 250 mg/m2. Cycle 2 was topotecan starting at 5 mg/m2, dose escalated in 2 mg/m2 increments, and etoposide 600 mg/m2. Cycle 3 was thiotepa 500 mg/m2. After each cycle, PBPCs were infused. Granulocyte colony stimulating factor (5 μg/kg/day) was administered until neutrophil recovery occurred. Seventeen patients were enrolled; all were safety evaluable. The most common nonhematologic toxicity was grade 3 mucositis (44%). Engraftment of PBPCs was successful in all patients after each cycle, and no treatment-related deaths occurred. Of 14 patients with measurable disease, 5 (36%) had complete responses, 2 (14%) had partial responses, and 4 (29%) had stable disease. The median progression-free and overall survivals were 7 and 18 months, respectively. The MTD of topotecan was not reached. The tolerability and activity of this regimen in patients with advanced ovarian cancer warrant further investigation.

  • carboplatin
  • high-dose chemotherapy
  • ovarian cancer
  • paclitaxel
  • thiotepa
  • topotecan

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